A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

A Follow-up Study on Safety and Tolerability and Pharmacodynamic Effect, of Patients With Idiopathic Parkinson's Disease (PD) of Moderate Severity, Who Have Previously Been Treated With sNN0031, Using an Implanted Catheter and a SynchroMed® II Pump

NCT01807338•Newron Sweden AB

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Summary

The purpose of this study is to document the long-term safety and tolerability after intracerebroventricular (ICV) administration of sNN0031 (PDGF-BB) in patients who participated in study sNN0031-001

Eligibility

Age

30 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Previous participation in study sNN0031-001 with completion of 12 study weeks without development of clinically significant safety concerns, defined as being any drug-related or device related serious adverse event that resulted in premature termination of treatment or a medical device incident that could not be resolved during the conduct of study sNN0031-001
•The patient has a diagnosis of idiopathic PD
•The patient has been given written and verbal information about the follow-up study, has had the opportunity to ask questions about the study, and understands the time and procedural commitments
•The patient has provided written informed consent to participate in the follow-up study

Exclusion Criteria

•The patient has been included or participates in another clinical study after participation in Study sNN0031-001
•The patient has, since participation in study sNN0031-001, had functional neurosurgical treatment for PD (e.g., deep brain stimulation).
•Patients will only be excluded from participation in the event of a laboratory test abnormality that is indicative of a medical condition requiring treatment which, in the opinion of the investigator, is not compatible with participation in the present study

Locations (1)

Department of Neurology, Skåne University Hospital

Lund, Sweden

Key Dates

Start Date

August 1, 2011

Primary Completion Date

August 1, 2014

Completion Date

August 1, 2014

Last Updated

October 9, 2014

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Follow-up Study on Safety and Tolerability of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

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